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Background: Genital herpes is a very common sexually transmitted disease. Safe and effective therapies are needed for patients with frequent recurrences. Objective: The aim of our study was to determine the efficacy and safety of famciclovir for suppression of herpes simplex virus (HSV) infection in patients with a history of clinically diagnosed recurrent genital HSV infection. Method: An analysis was conducted of the combined data from two randomized, double-blind, placebo-controlled studies of 52 weeks’ duration involving a total of 469 patients (201 men, 268 women) from 47 university, hospital, or private referral centers in Europe and North America. The patients were 18 years or older with a history of six or more episodes of genital herpes during 12 of the 24 months prior to study entry and were not receiving suppressive therapy. They were randomized to receive oral famciclovir 250 mg twice daily or placebo for 52 weeks. The primary outcome measures were (1) the proportion of patients who remained free from clinical HSV recurrences, confirmed by viral culture, for at least 6 months after the start of study medication; (2) the time to first clinically confirmed lesional episode; and (3) the frequency of adverse events. Results: A significantly greater proportion of famciclovir-treated patients (151/191, 79%) were free from HSV recurrences at 6 months compared with placebo recipients (48/184, 26%) (p < 0.001); efficacy was maintained at 12 months. The median time to the first clinically confirmed lesional episode was significantly prolonged for famciclovir recipients (more than one year) compared with placebo recipients (59 days; p < 0.0001). Famciclovir was well tolerated, with an adverse-experience profile comparable with placebo. Conclusions: Oral famciclovir 250 mg twice daily is an effective, well-tolerated treatment for the suppression of genital HSV infection in patients with frequent recurrences. [ABSTRACT FROM AUTHOR]